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FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
RecallFDA
Avkare Llc
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Oral Drugs·592 affected·Jun 13, 2023
High RiskFDA
K.c. Pharmaceuticals, Inc
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG h...
Ophthalmic Drugs·341,568 affected·Jun 13, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Diagnostic Devices·37 affected·Jun 13, 2023
High RiskFDA
Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Medical Devices·106 affected·Jun 13, 2023
CriticalFDA
Foremost Foods International, Inc.
Pamana brand Mini Fruit Jelly Cup 35.27 oz. Assorted Flavors 6 units per case Item #416705
Produce·11,040 affected·Jun 12, 2023
High RiskFDA
Wow Factor Desserts
WOW! Factor Desserts Berry Burst Slab Cake. Weight 2x8.15lbs UPC:10778463085373 Packaged in paper cartons.
Bakery & Grains·333 affected·Jun 12, 2023
High RiskFDA
S. Martinelli Harvest Facility
Martinelli's Gold Medal 100% Apple Juice 10 oz. glass bottles, 24 units per case Apple shaped glass bottles Shelf stable UPC: 041244000098
Beverages·2,387 affected·Jun 12, 2023
CriticalFDA
Foremost Foods International, Inc.
Pamana Brand Mini Fruit Jelly Cup 35.27 oz. Mango Flavor 6 units per case Item #416706
Produce·11,040 affected·Jun 12, 2023
RecallFDA
Gelato Boy
Gelato Boy Chocolate Chunk Gelato, frozen dessert, 24 month shelf life, paper cup and lid. 14 FL OZ, UPC: 853457008002, distributed by Ge...
Snacks & Candy·728 affected·Jun 12, 2023
High RiskFDA
Supplement Manufacturing Partner, Inc.
Havasu Beetroot Powder, 11.5 oz.
Food·1,501 affected·Jun 12, 2023
RecallFDA
Amring Pharmaceuticals Inc
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 1...
Oral Drugs·48,989 affected·Jun 12, 2023
High RiskFDA
Ferring Pharmaceuticals Inc
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufa...
Drugs·0 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. X-ray Image guided Therapy System.
Medical Devices·648 affected·Jun 12, 2023
CriticalFDA
Draeger Medical, Inc.
Oxylog 3000 Plus emergency and transport ventilator
Respiratory Devices·300 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Medical Devices·46,033 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·640 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 and FD20. X-ray Imaging System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·640 affected·Jun 12, 2023
High RiskFDA
Pepsico Beverages & Foods
Pearl Milling Company Self-Rising Yellow Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057380 packaged in paper bag with printed label
Food·91,760 affected·Jun 9, 2023
CriticalFDA
Richin Trading Inc
Sun Wave Brand Jelly Cup (Lychee Flavor); Made in Taiwan; Item Number 12152; UPC 715685121529; Net Weight 35.27 oz. (1000 g) Sun Wave B...
Food·141,192 affected·Jun 9, 2023
CriticalFDA
Richin Trading Inc
Sun Wave Brand Jelly Cup (Mango Flavor); Made in Taiwan; Item Number 12153; UPC 715685121536; Net Weight 35.27 oz. (1000 g) Sun Wave Br...
Food·141,192 affected·Jun 9, 2023
CriticalFDA
Richin Trading Inc
Sun Wave Brand Jelly Cup (Assorted Flavors); Made in Taiwan; Item Number 12151; UPC 715685121512; Net Weight 35.27 oz. (1000 g) Sun Wav...
Food·141,192 affected·Jun 9, 2023
High RiskFDA
Pepsico Beverages & Foods
Pearl Milling Company Self-Rising White Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057381 packaged in paper bag with printed label and Pea...
Food·412,760 affected·Jun 9, 2023
High RiskFDA
Botanas Michoacanas
Churritos Corn Flour sticks, shelf stable, 6 months shelf life, packed in a rectangular shape clear polypropylene bag with net wt.11 oz (...
Beverages·40 affected·Jun 8, 2023
High RiskFDA
Compass Usa
Fresh To You Chicken Filet Sandwich. MGF0635. Net Wt. 8oz. Perishable - Keep Refrigerated. Manufactured By MG Foods, Oak Creek, WI ...
Meat & Poultry·2,354 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Medical Devices·4 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Medical Devices·9,684 affected·Jun 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological ...
Medical Devices·62,704 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Medical Devices·1 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Medical Devices·284 affected·Jun 8, 2023
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Informatics Solution, Catalog Number 444150
Medical Devices·102 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Medical Devices·1,535 affected·Jun 8, 2023
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOn...
Medical Devices·3 affected·Jun 8, 2023
CriticalFDA
Oregon Potato Company
Rader Farms Organic Fresh Start Smoothie Blueberry, Strawberry, Raspberry, Kale, Spinach. Item # 1399671. Frozen, packed into 8oz. flexib...
Beverages·62,380 affected·Jun 7, 2023
CriticalFDA
Oregon Potato Company
Great Value Sliced Strawberries. Item # 107356. Frozen, packaged flexible plastic bags. Net wt. 4 lbs (64oz). UPC on retail bag: 0 78742 ...
Produce·28,650 affected·Jun 7, 2023
CriticalFDA
Oregon Potato Company
Great Value Mixed Fruit Pineapple, Strawberries, Peaches and Mango. Item # 107355. Frozen, packed into flexible plastic bags. Net wt. 4lb...
Produce·87,570 affected·Jun 7, 2023
CriticalFDA
Oregon Potato Company
Rader Farms Organic Berry Trio Strawberry, Blackberry, Raspberry. Item # 105872. Frozen, packed into flexible plastic bags. Net wt. 3lbs....
Produce·74,376 affected·Jun 7, 2023
High RiskFDA
Microvention Inc.
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, F...
Medical Devices·474 affected·Jun 7, 2023
High RiskFDA
Ptw-freiburg
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using Array...
Medical Devices·42 affected·Jun 7, 2023
RecallFDA
Hf Acquisition Co Llc
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Injectable Drugs·9 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Medical Implants·12 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Medical Implants·10 affected·Jun 6, 2023
CriticalFDA
Datex--ohmeda, Inc.
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; ...
Medical Devices·224 affected·Jun 6, 2023
High RiskFDA
Neurologica Corporation
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and ne...
Medical Devices·48 affected·Jun 6, 2023